How Many Times? SIX TIMES as Likely to Have Cardiac Arrest While Using GranuFlo

In 2011 the manufacturer of GranuFlo sent a company memo. The memo said that their medical staff had found that patients with excessive levels of bicarbonate in their blood were six to eight times more likely to have a cardiac arrest compared to those with normal levels. The memo also said that those who used GranuFlo may have increased levels of bicarbonate in their blood.

You read that right: those with increased bicarbonate levels in their blood are six to eight times more likely to suffer cardiac arrest — AND GranuFlo greatly increases the level of bicarbonate in a patient’s blood.

That means: patients using GranuFlo are six to eight times as likely to suffer cardiac arrest compared to patients who are not using GranuFlo as part of their dialysis treatment.

This was not one random study or theory. This was a company memo taken from real data that the company had and the data was so alarming that Fresenius Medical Center (the manufacturer of GranuFlo) took it upon themselves to alert members of their company and some of the members who worked at their dialysis centers across the country.

After all, Fresenius Medical Care is the world’s largest provider of kidney dialysis services and products, including GranuFlo and its sister dialysate NaturaLyte, and these products are used in thousands of dialysis centers across the country to treat kidney disease or failure. Some of these treatment centers are owned by Fresenius — hopefully, those treatment centers were alerted thanks to the internal memo. However, there are countless other treatment centers across the United States that are not Fresenius-owned dialysis treatment centers. Even still, they do use Fresenius products like GranuFlo and NaturaLyte — and should have been alerted with the same information.

But Fresenius did not take it any farther than that internal company memo. So, if you were a dialysis patient who happened to get your dialysis treatment from a company that was not directly run and owned by Fresenius Medical Care, you were out of luck. Because, while you may very well have received GranuFlo in your dialysis treatment, Fresenius Medical Center did not alert anyone outside of its company-wide bubble until forced to do so by the FDA five months later. It is not just unlucky, it was criminal, and real lives have been lost because of it.

According to the GranuFlo recall performed by the FDA in 2012, both GranuFlo and its sister drug NaturaLyte may cause low blood pressure, cardiac arrest or even death.

That’s the same conclusion the internal memo had found a year earlier. Only Fresenius Medical Center decided not to share that valuable information with the public. Think you know how many lives could have been spared from cardiac arrest had Fresenius followed that internal memo up with a public change of GranuFlo’s packaging and related marketing? We’d like to find out.